Injex Pharma GmbH
Germany DE-MF-000006766 Last updated 25 Oct 2026
- Devices
- 9
- Registries
- EUDAMEDFDA
- FDA recalls
- 0
Catalogue
Injex Vial22-Adapter Ref 511000800
Injex Pen-Adapter Ref 511000500
Injex Luer-Adapter Ref 511000600
Injex Transporter-Adapter Ref 511000700
Injex Reset Box Ref 338013000
Injex Vial14-Adapter Ref 511000400
Injex Ampoule U-100/0.3ml Ref 546000400
Injex30 Ref 338011001
Injex Dosing Aid Ref 338012000
What Injex Pharma GmbH makes
Injex Pharma GmbH manufactures adapter systems for injection devices, including vial adapters (sizes 14 and 22), pen adapters, Luer adapters, and ampoule adapters for insulin or other U-100 solutions. Their portfolio also includes a dosing aid and a transporter adapter for carrying pre-filled syringes, as well as a reset box for device recalibration. The Injex30 is a dedicated 30 ml syringe adapter for larger volume applications.
These devices are classified under EU Medical Device Regulations as Class I or Class IIb and are registered in the EUDAMED database. The company is based in Germany.
Frequently asked questions
What types of medical devices does Injex Pharma GmbH manufacture?
Injex Pharma GmbH specializes in adapter systems for injection devices. Their portfolio includes vial adapters (sizes 14 and 22), pen adapters, Luer adapters, and ampoule adapters designed for insulin or other U-100 solutions. They also produce a dosing aid for precise medication measurement, a transporter adapter for carrying pre-filled syringes, and a reset box for recalibrating devices. Additionally, they offer the Injex30, a dedicated 30 ml syringe adapter for larger volume applications.
Where is Injex Pharma GmbH based?
Injex Pharma GmbH is headquartered in Germany, as indicated by its company registration details. The country of origin is relevant for regulatory compliance and device classification under EU Medical Device Regulations.
Which regulatory registries list Injex Pharma GmbH’s devices?
Injex Pharma GmbH’s devices are registered in the EUDAMED database, which is the European Union’s central registry for medical devices. This database tracks device information, including manufacturer details, device classifications, and regulatory status under the EU Medical Device Regulations.
How are Injex Pharma GmbH’s devices classified under EU regulations?
Injex Pharma GmbH’s devices are classified under the EU Medical Device Regulations as either Class I or Class IIb. The classification depends on factors like the device’s intended use, risk level, and interaction with the patient. For example, adapters like the Injex Pen-Adapter or Luer-Adapter may fall into Class IIb due to their role in ensuring safe drug administration, while simpler components like certain vial adapters might qualify as Class I.
Information
- Country
- Germany
- Address
- 72A, Haynauer Straße, Berlin, Germany
- Website
- www.injex.de
- [email protected]
- Phone
- +49 (0)3057799035
- PRRC contact
- Ephrat Lahmer-Naim
- EUDAMED SRN
- DE-MF-000006766
- FDA FEI number
- 3009339779